Image

Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

Recruiting
35-55 years
Female
Phase 3

Powered by AI

Overview

This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.

Eligibility

Inclusion Criteria:

  • 35 years old <age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer
  • Stage: T2N0M0(cT>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)
  • Histologically confirmed HR+ (ER or PR positive, and >50% cell in IHC) HER2 negative breast cancer by pathological evaluation
  • No other previous treatment for primary breast cancer
  • Without other tumor or unstable complication or uncontrolled infection
  • No contradiction for the third generation AIs, LHRHa, chemotherapy
  • Attend the study voluntarily, sign the informed consent.

Exclusion Criteria:

  • Metastasis disease by pathological or radiological diagnosis
  • the history of other tumor
  • contradiction for the third generation AIs, LHRHa, chemotherapy
  • Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy
  • Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
  • other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
  • have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study

Study details
    Breast Cancer

NCT02535221

Peking University

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.